The Environmental Protection Agency will order the manufacturers of 19 chemicals used to make fragrances, dyes, explosives, fingerprinting agents, and many other products to conduct laboratory studies to provide basic health and environmental effects information about the compounds, according to a final rule published Jan. 7 in the Federal Register (76 Fed. Reg. 1067).
Under the rule, which is effective Feb. 7, Chemical manufacturers would have to submit study results from their research to EPA by March 2012 unless they receive a specific extension, the final regulation said.
Manufacturers are to submit by Feb. 7 a letter stating their intent to test the chemical or chemicals they make or submit an application seeking an exemption, the final regulation said.
“The public can track response to this rule by monitoring the public docket,” EPA spokeswoman Latisha Petteway told BNA. “Industry submissions of intent to test, test plans, test results, and other communications will be posted to the docket.”
If chemical manufacturers do not comply with the regulation, nontraditional manufacturers--such as companies that produce the chemicals as byproducts of other chemicals they manufacture, as impurities in other chemicals, or that process the chemicals--are on notice that they could be required to provide the data, EPA said. However, such companies should not plan to do so “unless they are notified by EPA that they are required to,” the final regulation said.
EPA will publish a second Federal Register notice specifying the chemicals that would need to be tested and the tests that would have to be conducted if none of the traditional manufacturers notifies the agency of its intent to conduct one or more of the required tests, Petteway said.
The rule will be the second final test rule to stem from the voluntary High Production Volume (HPV) Challenge Program launched in 1998 by then-Vice President Al Gore.
On April 21, 1998, Gore challenged manufacturers of high production volume chemicals, which are those made in or imported into the United States in volumes of 1 million pounds or more, to voluntarily make basic health and environmental effects data on the compounds publicly available.
Many manufacturers did. As of June 2007, according to EPA, companies have agreed to provide data on more than 2,200 HPV chemicals through the HPV program and an international counterpart managed by the Organization for Economic Cooperation and Development (OECD).
The second test rule targets 19 chemicals for which data were not voluntarily provided. The chemicals are so-called “orphan” chemicals. EPA proposed the test rule for these 19 orphans in July 2008 (32 CRR 734, 7/28/08)
EPA expects to publish another final HPV test rule and to propose a fourth by April, according to the agency latest regulatory agenda, published Dec. 20.
The American Chemistry Council, which represents major chemical manufacturers and which has long supported EPA's effort to require data on “orphan” HPV chemicals, affirmed its support for the agency's latest regulatory effort.
“From the outset of the HPV program, ACC and our members have been working closely with the EPA to help ensure chemical safety information is widely available,” council spokesman Scott Jensen said in a statement. “We are encouraged by this latest action by the EPA as it takes appropriate steps to collect the information needed to review priority chemicals.”
The 19 chemicals subject to the final test rule are:
• acetaldehyde (CAS No. 75-07-0);
• 1,3 propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester), (CAS No.78-11-5);
• 9,10-anthracenedione (CAS No. 84-65-1);
• 1H, 3H-benzoΏ,2-c:4,5-c']difuran-1,3,5,7-tetrone (CAS No. 89-32-7);
• 2,4-hexadienoic acid, (E,E), (CAS No. 110-44-1);
• phenol, 4, 4'-methylenebisΐ,6-bis(1,1-dimethylethyl), (CAS No. 118-82-1);
• diphenylmethanone (CAS No. 119-61-9);
• ethanedioic acid (CAS No. 144-62-7);
• methanesulfinic acid, hydroxy-, monosodium salt (CAS No.149-44-0);
• phosphorochloridothioic acid, O, O-diethyl ester (CAS No. 2524-04-1);
• 1, 3, 5-triazine-1,3,5(2H,4H,6H)-triethanol (CAS No. 4719-04-4);
• D-erythro-hex-2-enonic acid, gamma.-lactone, monosodium salt (CAS No. 6381-77-7);
• D-gluco-heptonic acid, monosodium salt, (2.xi.), (CAS No. 31138-65-5);
• C.I. Leuco Sulphur Black 1 (CAS No. 66241-11-0);
• castor oil, sulfated, sodium salt (CAS No. 68187-76-8);
• castor oil, oxidized (CAS No. 68187-84-8);
• benzenediamine, ar,ar-diethyl-ar-methyl (CAS No. 68479-98-1);
• alkenes, C12-24, chloro (CAS No. 68527-02-6); and
• hydrocarbons, C >4 (CAS No. 68647-60-9).
The final rule does not describe the ways these chemicals are used. In an announcement accompanying the regulation, however, EPA said they have “many consumer and industrial applications.”
Acetaldehyde, for example, is primarily used to make other chemicals but also used in the production of perfumes, polyester resins, and dyes, according to EPA information.
C12-24 chloro alkenes are used as metalworking fluids, EPA's announcement said.
Ethanedioic acid, or oxalic acid, is an inert ingredient in pesticides and also used in textile finishing; in metal, wood, or equipment cleaning; in bleaching straw hats and leather; in removing paint, varnish, and rust or in stains; and in the paper industry, according to information from EPA's Office of Pesticide Programs.
EPA is not requiring that all the tests proposed in July 2008 be conducted, according to the final rule. Based on information received from chemical manufacturers and animal welfare groups, among other sources, EPA tailored the testing orders to provide data not publicly available, the agency said.
By Pat Rizzuto
A prepublication copy of EPA's final rule ordering test data for the 19 chemicals is available at http://www.epa.gov/hpv/pubs/general/hpv2%20prepublication%20notice.pdf.
Parties wishing to track response to EPA's regulation can do so by monitoring docket no. EPA-HQ-OPPT-2007-0531 at http://www.regulations.gov.
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